RecruitingACTRN12610000039088

Lung function measurement to predict the response to changes in the dose of inhaled corticosteroids among asthmatic patients taking combination therapy

Sponsor

The Woolcock Institute of Medical Research

Enrollment

60 participants

Start Date

May 11, 2009

Study Type

Interventional

Conditions

Lung function Asthma

Summary

The aim of the study is to evaluate the ability of various physiological and inflammatory markers to predict changes in asthma control following changes in the dose of combination therapy. The direction and magnitude of the dose changes are determined for each patient by their baseline level of asthma control. If the baseline variables, either alone or in combination, can predict future benefit or risk from change in treatment then the study will provide new insights into the clinical management of asthma.

Eligibility

Sex: Both males and femalesMin Age: 17 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether certain breathing test results and airway measurements in people with asthma can predict how their asthma control will change when the dose of their inhaled combination therapy (steroid plus bronchodilator) is increased or decreased. The aim is to help doctors personalise asthma treatment more effectively. You may be eligible if: - You are between 17 and 70 years old - You have a doctor-confirmed asthma diagnosis - You are a non-smoker - You are currently using preventer (inhaled corticosteroid) medication for active asthma You may NOT be eligible if: - You are pregnant - You currently smoke - You have previously been intubated (put on a breathing machine) for a severe asthma attack Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Measurement of lung function at baseline and at review (spirometry, lung volumes). Measurement of lung biomarkers at baseline and at review (exhaled nitric oxide, multiple breath nitrogen washout, fo

Measurement of lung function at baseline and at review (spirometry, lung volumes). Measurement of lung biomarkers at baseline and at review (exhaled nitric oxide, multiple breath nitrogen washout, forced oscillation device, sputum induction). Dose adjustment of inhaled corticosteroids based on baseline level of asthma control. The frequency of the medication treatment remains the same for each individual patient as it was prior to entry into the study: If patients are not well-controlled at baseline, then the inhaled corticosteroid dose will be doubled over the 8-week period. If patients are well-controlled at baseline, the inhaled corticosteroid dose will be halved in the first 4 weeks and quartered over the subsequent 4 weeks. Patients are reviewed at the end of the 8-week period. If patients remain well-controlled after the initial 8-week period, then patients can stop their inhaled corticosteroid and continue to be monitored over another 8-week period. Patients can return for review if their asthma control worsens at any stage during the study. This is an end-point for the study. In this instance, patients are treated as clinically indicated and will return to the care of their usual treating doctor after the study.